Digital Management: Solving Medical Device Labeling & Compliance Challenges

The medical device industry is projected to grow to over $600B by 2023, presenting massive opportunities for many, but also immense challenges and greater strain on supply chains – from manufacturing to material handling and distribution.

In fact, few industries are as complex and highly regulated as medical devices. Regulations can vary dramatically across borders, approval processes can be lengthy, non-compliance penalties lead to costly setbacks or shipping delays, and turnaround times are constantly shortened by competition.

Overcoming these challenges can be crucial to success for years to come. But dated labeling processes, like locally managing disparate label data sources and printers across facilities or manually hard coding thousands of label templates, just aren’t cutting it.

Times are changing, and so are supply chains. Simply put, taking a modern, digital approach to labeling can be the secret sauce for any medical device manufacturer to stay compliant, gain a competitive edge and improve supply chain operations on a global scale.

The Challenge of Compliance Across Borders

Medical device manufacturers hoping to operate internationally need to ensure they align their labeling with varying standards, like the US Food and Drug Administration’s (FDA) rules and the EU Medical Device Regulation (MDR).

In many cases, small differences between regulations can be highly consequential. For instance, a medical manufacturer shipping to the US that has already met FDA compliance may be 90% of the way to complying with MDR as well. However, a multitude of nuanced differences can require varying designs that could be costly and can quickly halt a supply chain in its tracks.

Small label design changes, like meeting the MDR requirement to label medical devices with an MD symbol in a box, can become big challenges when manufacturers try to manually make changes, which can lead to errors causing noncompliance or having to tap into IT resources to code label changes; thereby, increasing labor requirements.

Streamlining Labeling with Dynamic Templates and Integration

Whether shipping domestically or overseas, streamlining label management can provide a plethora of benefits. For instance, switching from hard-coded templates to dynamic ones will ease the burden on IT caused by cumbersome design changes. Furthermore, teams can digitize entire quality assurance and control processes, so manufacturers can implement better workflows for label changes and approvals, without manual processes like printed proofs.

Going a step further, manufacturers can even automate label change and approval processes on a large scale across multiple locations, which eliminates the need to individually design and approve hundreds or thousands of labels for each stock keeping unit (SKU). To be able to do this it helps to have a label management system that can automate mass label changes and approvals with the approved label template for each SKU locked down and ready for production where you can add production identifier (PI) data. Having seamless integration with product lifecycle management (PLM), manufacturing execution (MES) and enterprise resources planning (ERP) systems helps to further streamline the process.

Integration is vital because PLM, MES and ERP systems are the truth source for crucial info like the device identifier (DI) and PI data needed to satisfy multiple regulations, such as portions of both the US FDA and EU MDR requirements.

Moving to the Cloud: A Key to Easing Label Design and Validation

Cloud-based label management systems are becoming indispensable for many medical device manufacturers, especially for those who don’t want, or can’t afford, to invest in the fixed costs of an on-premise label management system.

By using a cloud-based labeling system designed for medical device labeling, organizations can quickly integrate labeling with other systems and gain access to crucial tools like validation documentation and readily compliant label templates that are updated on a regular basis to ensure compliance.

From a workflow standpoint, cloud-based systems can also make it easier to manage designs and compliance with capabilities like role-based access to documents, version control, configurable approval processes and an extended print history with a detailed record of what was printed and when.

Future-proofing Labeling

The ability to efficiently ensure compliance, no matter where devices are shipped or what regulations change, is becoming increasingly important. This is why technologies like digital label management or cloud-based solutions that make implementing label management easier than ever are quickly becoming an essential component to any medical device manufacturer’s arsenal. So, if you’re still feeling lost and overwhelmed by the challenges of compliant labeling, it may be time for a digital refresh.

Susan GosnellAbout the Author

Susan Gosnell is a product marketing manager at NiceLabel. NiceLabel provides label design software and label management systems. The company recently introduced the world’s first, public, validation-ready cloud labeling solution. During her six years at NiceLabel, Susan has focused on the digital transformation of labeling for regulated companies. She has held various marketing roles in the supply chain and data security software industries for over 20 years.

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